(June 2022)
Novel foods are non-traditional foods that require assessment by FSANZ to establish their safety before they are added to the food supply.
In Australia and New Zealand, novel foods and novel food ingredients are regulated under Standards 1.1.1 and 1.5.1 in the Australia New Zealand Food Standards Code (the Code).
A novel food cannot be a food for retail sale or an ingredient in a food for retail sale unless it is listed in the table to section S25 - 2 (sale of novel foods) of the Code. The table lists permitted novel foods together with their conditions for use including use levels, restrictions on use and labelling requirements.
Anyone wanting to sell a novel food or a food containing a novel food ingredient must apply to FSANZ for the Code to be amended to list the food or ingredient in the table at section S25 - 2. Novel food applications are subject to a statutory assessment which includes a pre-market safety assessment. If approved, the food will be listed in the table and the manufacturer will be permitted to sell the product, as long as it complies with any specified conditions.
You can find the definitions of 'non-traditional food' and 'novel food' in section 1.1.2 - 8 of Standard 1.1.2 of the Code.
Determining whether a food is considered novel
There are a number of approaches to determining whether a food is novel.
You may wish to obtain advice from the relevant food enforcement agency and/or obtain your own legal advice about whether a food is a novel food.
You can also approach the Advisory Committee on Novel Foods (ACNF) to make a recommendation about whether a food is novel.
The ACNF considers whether particular foods meet the definition of 'non-traditional food' in the Standard and, if so, whether a safety assessment needs to be done. It uses a guidance tool to assist it in reaching its view on whether a food is novel or not.
Once the ACNF completes its assessment of a food, it provides a recommendation about whether the food is a novel food for the purposes of the Code. These recommendations are published on the FSANZ website.
The ACNF will not produce a recommendation for every enquiry they receive. For example, after considering an enquiry, the ACNF may require more information in order to produce a recommendation. Therefore some enquiries discussed by the ACNF will not have a recommendation published on the FSANZ website.
The ACNF recommendations are not legal advice and are not legally binding. They are also not advice, recommendations, or decisions by FSANZ on whether a food is or is not a novel food. The recommendations provided by the ACNF are only to help enquirers make their own decision on whether they should submit an application seeking to amend the Code.
There is no legal requirement to seek a recommendation or opinion from the ACNF.
In addition, the ACNF recommendation on whether a safety assessment is required is not a pre-market safety assessment, rather it is preliminary hazard identification step in the context of the risk analysis framework. The pre-market safety assessment is part of FSANZ's assessment of an application to amend the Code.
More information about making an application to FSANZ to amend the Standard can be found in the Application Handbook.
Submitting an enquiry to the ACNF
You will need to complete a questionnaire (PDF 30KB) before the Committee can consider your enquiry. Send your completed questionnaire to acnf@foodstandards.gov.au. You should also look at the guidance tool before completing the questionnaire.
Alternatively, you can proceed directly to submitting an application to FSANZ seeking to amend the Code to permit a food which, in your opinion and according to any legal advice you receive, meets the definition of 'novel food' in Standard 1.1.2.
Public health and safety consideration of novel foods
Novel food applications are subject to a statutory assessment by FSANZ that includes a risk-based public health and safety assessment. This process ensures the safety of novel foods before they can be a food for retail sale or an ingredient in a food for retail sale in Australia and New Zealand.
The purpose of this assessment is to evaluate the potential impact of permitting the novel food on public health and safety. When we evaluate the public health and safety of a novel food or novel food ingredient, we consider a variety of toxicological and nutritional issues together with information about its chemistry and how much of it we expect people to eat.
Exclusivity of use for novel foods
Applicants requesting permission for a novel food to be a food for retail sale or included in a food for retail sale may also request that permission be subject to a period of 'exclusive' use for up to 15 months.
See Exclusivity of use for novel foods and nutritive substances for further information on exclusivity of use.
Enforcement
FSANZ does not enforce the Food Standards Code. This is the responsibility of food enforcement agencies in Australia and New Zealand. See What we do and don't do.